Lanreotide Significantly Prolongs Progression-Free Survival in Metastatic Gastroenteropancreatic Neuroendocrine Tumors
Although somatostatin analogs are commonly used to treat symptoms associated with hormone hypersecretion in neuroendocrine tumors, data on their antitumor effects are limited. In the phase III CLARINET trial reported in The New England Journal of Medicine, Caplin et al found that somatostatin analog lanreotide (Somatuline Depot) injection significantly prolonged progression-free survival over placebo in patients with metastatic gastroenteropancreatic neuroendocrine tumors.
Study Details
This investigational, randomized, double-blind, placebo-controlled study was conducted in 48 centers in 14 countries and included data from 204 patients with gastroenteropancreatic neuroendocrine tumors. Patients with well or moderately differentiated nonfunctioning enteropathic neuroendocrine tumors and a proliferation index of < 10% were randomly assigned to lanreotide at 120 mg (n = 101) or placebo (n = 103) once every 28 days for 96 weeks.
The primary endpoint was progression-free survival, defined as time to either disease progression or death. Secondary endpoints included overall survival, quality of life, and safety. Baseline computed tomography or magnetic imaging scans were performed, followed by additional scans at 12-week intervals during the first year and 24-week intervals during the second year up to 96 weeks.
Prolonged Progression-Free Survival
Lanreotide was associated with a significantly prolonged progression-free survival compared to placebo, with median progression-free survival not being reached in the lanreotide arm vs 18 months in the placebo arm. At 96 weeks, 33% (95% confidence interval [CI] = 23.0–43.3) of patients in the placebo arm had not progressed or died compared to 65.1% (95% CI = 54.0–74.1) in the lanreotide arm. This represented a 53% reduction in risk of disease progression or death based on a hazard ratio of 0.47 (95% CI= 0.30–0.73).
Safety data were consistent with the known safety profile of lanreotide. Half of the patients in the lanreotide group experienced treatment-related adverse events vs 28% with placebo, the most common being diarrhea (26% vs 9%).
“The CLARINET data are compelling, since no similar [gastroenteropancreatic neuroendocrine tumors] progression-free survival data exist for a somatostatin analog in such a large, multinational study population,” said lead author and principal investigator Martyn Caplin, MD, Professor of Gastroenterology & Gastrointestinal Neuroendocrinology, Royal Free Hospital, London, in statement.
Dr. Caplin is the corresponding author for The New England Journal of Medicine article.
The study was sponsored by Ipsen. For full disclosures of the study authors, visit www.nejm.org.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
